Single Ascending Dose Study With BPL-003 in Healthy Subjects

Beckley Psytech

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics in Healthy Adults

Treatments: Drug: BPL-003; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05347849

BPL-003-103

Details and patient eligibility

About

The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects

Enrollment: 62 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medically healthy based on medical records and study specific assessments

Exclusion criteria

• Presence or history of severe adverse reaction to any drug or drug excipient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

BPL-003 arm

Experimental group

Treatment:

Drug: BPL-003

Placebo arm

Placebo Comparator group

Treatment:

Other: Placebo